OTC distribution of antimicrobial medicines was barely mentioned during the United Nations General Assembly High-Level Meeting on Antimicrobial Resistance in New York on 26 September, according to the Global Self-Care Federation.
Nevertheless, the political declaration approved at this meeting still contains what industry insists is a misunderstanding about what “over-the-counter” actually means.
GSCF and the UK industry association, PAGB, think that the resolution is really targeting the misuse of prescription products, which are in some cases being supplied or sold to consumers illegally, without proper prescription, diagnosis or healthcare professional interaction.
With an unamended declaration, the task going forward, then, is for national associations to lobby their local governments to make sure this misunderstanding does not make its way into local or regional policy.
Notable Absence
“Last week marked a pivotal moment for global health as world leaders approved a political declaration on Antimicrobial Resistance (AMR) at the 79th United Nations General Assembly (UNGA) High-Level Meeting,” noted GSCF. “This declaration sets clear targets and actions aimed at reducing the estimated 4.95m annual deaths linked to AMR.”
“During the meeting’s opening session, the honorary chairs emphasized three critical drivers of AMR: antibiotic misuse, environmental contamination, and livestock agriculture. Notably absent from the discussions was the issue of over-the-counter medications, but the private sector’s vital role in combating AMR was consistently highlighted.”
The global consumer healthcare industry, which markets commonly used OTC antimicrobial products for self-treatable conditions like thrush, facial herpes and athlete’s foot, was concerned that the meeting would advocate for a restriction on such products, based on wording in the political declaration.
Among the commitments of the declaration – the text of which was approved and will now be submitted to the General Assembly for final adoption – is to “acknowledge the drivers of antimicrobial resistance, including … lack of regulation of over-the-counter use of antimicrobials,” as well as “over-prescription by health care workers.”
However, “misuse and over-prescription of antibiotics are the primary drivers of AMR,” GSCF insisted, “not the regulated use of non-prescription antimicrobial products.
Misunderstanding
Industry, however, is concerned that the resolution incorrectly implies that the UNGA is advocating for a restriction on sales of commonly used non-prescription antimicrobials, such as topical antifungal thrush and foot creams and antiviral cold sore treatments.
“In some countries, there can be misuse of prescription products, which may result in prescription medicines being supplied or sold to a consumer illegally, without proper prescription, diagnosis or healthcare professional interaction,” GSCF pointed out. “This can happen in markets where there is a lack of regulation or enforcement of regulation.”
PAGB, which has already seen some success with lobbying UK stakeholders to make sure they have a correct understanding of the issue, has also suggested that concerns about commonly used OTC antimicrobials and antimicrobial resistance could be based on a simple misunderstanding.
“It’s not about OTCs at all. It’s about the OTC setting,” PAGB CEO Michelle Riddalls recently told HBW Insight in an exclusive interview. “It just so happens that people are getting antibiotics in an OTC a setting. But it’s not the OTC antimicrobials themselves that are the problem. It’s about a lack of stewardship.”
Next Steps
While UN political declarations are not legally binding, they are intended, according to the UN Charter (Article 13), to “promote international co-operation in the political field” and “encourage the progressive development of international law and its codification.”
In other words, resolutions are intended to exert an influence over national policymaking.
The task for industry, then, is to “ensure the promotion of safe and correct use of OTC antimicrobials, which include antivirals, antiseptics, antifungal, and a few antibiotics available OTC in a handful of high-income countries,” GSCF told HBW Insight.
“This trickles down practically into becoming the global reference on guidance on OTC antimicrobials (producing guidance with relevant stakeholders, etc.) and improving individual outcomes in reference to their use,” it continued.
“We are also gathering evidence at the country level to prevent faulty references to OTC antimicrobials in AMR containment activity plans, when the need arises.”
Lobbying
National associations can also take a leaf out of PAGB’s book, lobbying local stakeholders to make sure they are aligned as much as possible with industry’s understanding of the issue and with regards to the correct language that needs to be used.
“Mapping stakeholders, finding out what they think and then making sure they have all the information, so that everyone is very aware of what’s going on,” is a good first step, Riddalls explained.
Riddalls and other members of a GSCF working group – which also includes the Association of the European Self-Care Industry and its extensive experience of dealing with this issue at an EU level – are also meeting frequently to closely track developments.
